[Federal Register Volume 63, Number 55 (Monday, March 23, 1998)]
[Notices]
[Pages 13865-13866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7475]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0488]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
April 22, 1998.
ADDRESSES: Submit written comments on the collection of information to
Office of Information and Regulatory Affairs, OMB, New Executive Office
Bldg., 725 17th St. NW., rm. 10235, Washington, DC, 20503, Attn: Desk
Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Year 1998 and 2000 Continuation of National Surveys of Prescription
Drug Information Provided to Patients--(OMB Control Number 0910-
0279--Reinstatement)
FDA implements the provisions of the Federal Food, Drug, and
Cosmetic Act ( the act), designed to assure the adequate labeling of
prescription (Rx) drugs. Under section 502(a) of the act (21 U.S.C.
352(a)), a drug product is misbranded if its labeling is false or
misleading in any particular, and under section 201(n) of the act (21
U.S.C. 321(n)), a drug's labeling is misleading if its labeling or
advertising fails to reveal material facts. FDA also has the authority
to collect this information under Title VI of Pub. L. 104-180 (Related
Agencies and Food and Drug Administration) section 601 (Effective
Medication Guides), which directs the development of ``a mechanism to
assess periodically * * * the frequency with which the [oral and
written prescription] information is provided to consumers.''
To assure that Rx drugs are not misbranded, FDA has historically
asserted that adequate labeling requires certain information be
provided to patients. In 1982, when FDA revoked a planned initiative to
require mandatory patient package inserts for all Rx drugs in favor of
private sector initiatives in this area, the agency indicated that it
will periodically conduct surveys to evaluate the availability of
adequate patient information on a nationwide basis. Surveys of
consumers about their receipt of Rx drug information were carried out
in 1982, 1984, 1992, 1994, and 1996. This notice is in regard to
continuing the survey in years 1998 and 2000.
The survey is conducted by telephone on a national random sample of
adults age 18 and over who received a new prescription for themselves
or a household member within the past 4 weeks. The interview assesses
the extent to which oral and written information was received from the
doctor, the pharmacist, and other sources. Survey respondents are also
asked attitudinal questions, and demographic and other background
characteristics are also obtained. The survey enables FDA to determine
the frequency with which such information is provided to consumers.
Without this information, the agency would be unable to assure that
adequate Rx labeling and information is provided.
Respondents to this collection of information are adults (18 years
or older), in the continental United States who have obtained one or
more new (nonrefill) prescriptions at a pharmacy for themselves or a
member of their household in the last 4 weeks.
In the Federal Register of December 11, 1997 (62 FR 65273), the
agency invited comments on the collections of information. No
significant comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden: Screener1
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Annual
Year No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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1998 11,044 1 11,044 .03 331
1999 0 0 0 0 0
2000 11,044 1 11,044 .03 331
Annual average 7,363 7,363 221
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 13866]]
Table 2.--Annual Reporting Burden: Survey1
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Annual
Year No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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1998 1,000 1 1,000 .32 320
1999 0 0 0 0 0
2000 1,000 1 1,000 .32 320
Annual average 667 667 213
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
This estimate of 434 total annual burden hours is based on the 1996
survey administration, in which 11,044 potential respondents were
contacted to obtain 1,000 interviews.
Dated: March 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7475 Filed 3-20-98; 8:45 am]
BILLING CODE 4160-01-F
